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Biocartis Licenses EGFR Marker for Colon Cancer Test; Unveils New MDx System, BRAF Assay

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This story has been updated from a previous version to include information about Biocartis' newly branded MDx platform and AACR presentation.

Swiss molecular diagnostics firm Biocartis has taken a pair of important steps in its quest to become a provider of molecular diagnostic tests for personalized medicine.

This week, the Lausanne-based company introduced Idylla, the brand name for its fully automated, sample-to-answer, research-use-only molecular diagnostics system. Previously codenamed Apollo, Idylla will be Biocartis' flagship platform for in vitro diagnostic use.

In addition, Biocartis and collaborators from MD Anderson Cancer Center this week presented data at an American Association for Cancer Research satellite conference from a study demonstrating that Idylla can detect BRAF mutations in melanoma and other cancer types much faster than and nearly as accurately as the CLIA-approved molecular method.

And last week Biocartis disclosed that it has licensed an EGFR biomarker from Hospital del Mar in Barcelona, Spain, in order to develop a molecular diagnostic test to help guide colon cancer treatment. Biocartis could also develop this test on the Idylla platform, which can simultaneously detect up to 30 molecular targets in a single test cartridge; or on another, more highly multiplexed biomarker analysis platform called DMAT, which can detect up to 200 analytes from a single sample, and which is currently under development at the firm.

"Our goal is to provide the complete hyperplexed mix of different types of nucleic acid markers which are actionable for a given patient and physician situation," Biocartis CSO Geert Maertens told PCR Insider in an email.

In the abstract presented this week at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, a team led by MD Anderson oncologist Filip Janku used 79 archival tumor samples to test the MDx Idylla BRAF assay. The BRAF mutation status of all the samples, obtained using a CLIA-approved method that combines PCR-based sequencing and Sequenom MassArray analysis, was already available for the samples.

According to the results of the study, the Biocartis platform and CLIA-approved method agreed for 75 of the 79 samples. Of the four samples with discrepancies, the Biocartis platform but not the CLIA-approved method detected a BRAF V600E mutation in one colon cancer sample; and Idylla did not detect BRAF mutations in the remaining three samples that were reported to be BRAF-mutation positive by the CLIA-approved method.

Also of note, two of the three patients whose tumor samples tested positive for BRAF mutations by the CLIA-approved method but not the Biocartis platform were treated with BRAF/MEK inhibitors based on the CLIA results, and they did not respond to treatment.

Overall, the Idylla BRAF mutation assay showed 96 percent concordance with CLIA laboratory results in identical tissue blocks, but was much faster and easier to implement, the researchers noted.

"When you do molecular testing for BRAF mutations the way it is done in the clinic, it often takes three to four weeks to get the results back," Janku said in a statement. "A lot of that time is spent preparing the sample, including laser microdissection, to isolate DNA from the tumor cells."

With the Idylla platform, he added, "it takes about two minutes to add fresh, frozen, or paraffin-embedded tumor samples to the sample cartridge and less than 90 minutes to get the results. This platform is capable of giving you an answer in an absolutely unprecedented time frame."

The Idylla platform is still RUO, but Biocartis said that it plans to launch the system and the BRAF test in Europe in the second half of 2014.

Meantime, last week Biocartis disclosed its recent deal with Hospital del Mar for the EGFR biomarker.

Researchers from the hospital previously showed that colon cancer patients with an S492R mutation in the EGFR gene do not respond to treatment with the colon cancer drug cetuximab (sold as Erbitux in Europe by Merck KGaA), but remain sensitive to treatment with panitumumab (Vectibix, Amgen).

The researchers reported these findings in a paper published last September in Nature Medicine.

In addition, an independent team of researchers from MD Anderson described the same S492R EGFR mutation in 4 of 55 patients in an abstract presented at the American Society of Clinical Oncology meeting earlier this year in Chicago.

Biocartis plans to use the biomarker to develop a molecular assay to help guide colon cancer treatment. This assay will be nucleic acid-based and suitable for use on either the Idylla or DMAT platform, the latter of which is also under development, Maertens said.

"A custom prototype version of the assay is [being] used in a larger prospective study at Hospital del Mar to determine the prevalence of the acquired mutations under cetuximab treatment," he said.

The DMAT, or Dynamic Multi-Analyte Technology, is the internal working name of a Biocartis assay platform that uses disposable, microfluidic cartridges to rapidly and sensitively detect up to 200 different analytes from a single sample, according to the company's website. The platform achieves this using proprietary coded silicon particles, microfluidics, and microfabrication technologies.

Idylla, meantime, integrates various semiconductor technologies and design elements from the consumer electronics industry, along with established molecular detection technologies. It is a compact, benchtop, cartridge-based system that can simultaneously detect up to 30 molecular targets in a single cartridge.

Biocartis had been developing infectious disease diagnostics for the Idylla platform along with BioMérieux, which in 2010 established a partnership with Biocartis and took a €9 million stake in the firm.

That program hit a speed bump this year, however, as BioMérieux announced in September that it had acquired BioFire Diagnostics for $450 million plus undisclosed debt, primarily for that company's FilmArray platform for molecular infectious disease diagnostics (PCR Insider 9/5/2013). BioMérieux also noted at the time that it was reevaluating its relationship with Biocartis.

The status of BioCartis' infectious disease diagnostic program is currently unclear, but it appears to be full steam ahead for its molecular oncology diagnostic program, with both the Idylla and DMAT technologies leading the charge.

Maartens noted that the company also has an EGFR mutation assay in the works for lung cancer; and in May Biocartis announced that it was collaborating with the Wellcome Trust Sanger Institute and Philips Research to develop a workflow to extract and amplify circulating tumor DNA from blood samples for downstream analysis on the DMAT, and possibly, the Idylla platform (PCR Insider 5/31/2012).

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